2011: Ethics of dementia research
Epidemiology is the study of disease distribution in populations and of factors which affect the distribution of such disease. The emphasis is on the health of the entire population rather than the health of individuals (Childress et al., 2002). This may be measured in terms of incidence (the number of new cases or deaths which occur in a specified time, usually one year) or prevalence (the total number of new and existing cases at a given time).
Researchers explore environmental and personal characteristics which vary by place, time and sub-group of the population in their search for relationships between these various factors and diseases. The interest of epidemiological researchers is in determining the likely cause of a particular condition or disease in order to be able to determine what the best response might be. Epidemiological research is concerned with correlations and not causal relationships. Researchers in this domain generate theory and make educated, informed assertions about which relationships are causal and in what way, based on their findings. This approach is sometimes called general causation (as opposed to specific causation) (Wikipedia, 2011).
To do this, they tend to use observational methods which include the study of available statistics, the careful questioning of patients, systematic routine medical history taking of patients and control groups, small and large scale case studies, large scale cohort studies where a group of people are monitored over a long period of time, and experimental studies such as randomised controlled trials (Gale Encyclopedia of Public Health, 2011).
With case control studies, researchers take two groups (one with the condition and one without) and look back to try to determine which factors they experienced or were exposed to. Cohort studies, on the other hand, take two groups, neither of which have the condition, but are different in some significant way (e.g. linked to alcohol consumption or smoking) and over time observe the incidence of the condition of interest on each group.
As the factors explored are extremely diverse, epidemiology draws on numerous domains such as microbiology, physics, engineering, town planning, immunology and genetics, to name but a few.
The attribution of responsibility and “blaming the victim”
According to the attribution theory of Weiner et al. (1988), people tend to make three attributions about a perceived group difference (which could include a medical condition such as dementia or, of relevance to the next sub-section, a person’s genetic status). First, they consider controllability (i.e. whether the person had any control over contraction of the disease or the situation occurring). Second, they make attributions about responsibility (i.e. whether the person had any control over this and could have prevented it from occurring as if so, s/he may be considered responsible for his/her current situation/condition). Finally, if it is thought that the condition/situation could have been prevented, the person may be blamed for not having done so. This process of attribution has been shown to have an impact on the emotional response to people with a particular perceived group difference and on the behavioural response towards those people.
Research which uncovers causal relationships between various factors and dementia (whether these be environmental, genetic, life style or other) may have a double effect in that in addition to enabling people, in some cases, to take precautionary measures to prevent or delay onset of the disease, or to make plans for the future, it may result in a lack of sympathy towards people who may be blamed for having dementia.
Raising false hopes
Just as some people may readily blame others for their condition, others may be overly optimistic about their chances of preventing a particular condition from occurring. In both cases, this may be based on the interpretation of the results of epidemiological studies (amongst others). This requires ethical reporting of the results of studies (please see sub-section 10 on the publication and dissemination of research).
Avoiding common pitfalls
Epidemiological studies, and various types of longitudinal cohort studies, carried out by public health researchers, often cost a lot of time, effort and money. Such studies require considerable effort and dedication on the part of the participants. They may be asked to fill out endless questionnaires, be submitted to batteries of tests and have to regularly monitor or record their behaviour or information about themselves. Anything which disrupts the effective conduct of the study could therefore have consequences for all concerned in terms of a wasted personal or financial investment.
Common pitfalls to such studies include bias, confounding factors (i.e. possible alternative explanations for the correlations) and an insufficient sample size. It would be unethical to expend such considerable resources without having taken the necessary measures to address these issues.
Communication of findings
Epidemiological researchers have an ethical responsibility towards society and in some cases towards particular communities to communicate their findings in a timely and appropriate manner so that people can benefit from the information (Coughlin, 2006). Findings must therefore be communicated after appropriate scientific peer review in a way that is understandable to those most likely to be concerned by such information. In some cases, those most concerned by particular findings, may be members of communities with specific characteristics (e.g. based on residency rights, living conditions, language and cultural beliefs and practices) which serve as a barrier to the communication of findings by conventional means.
Individual rights, societal benefits and paternalism
The need to balance the rights and wellbeing of the individual research participant with the perceived potential benefit to society applies to research in general, including dementia research. In the case of studies which explore various factors which may be common in certain cultural groups or amongst certain groups in society rather than in others, research findings may eventually result in restrictions being placed on the former which restrict their autonomy. Smoking is an obvious example. In some cases, there may be valid arguments linked to the protection of the wellbeing of other members of society (i.e. those who do not smoke), whereas in other cases, restrictive measures may eventually be taken by the state which simply affect the individual rights of those engaging in the activity or exposed to a particular factor. Attempts by the state to change habits of diet, exercise and smoking etc. may be covert or overt.
Depending on specific circumstances, this could be construed as the rightful role of the state to protect its citizens or as paternalism. According to Lappe (1986), the moral justification of various compulsory public health interventions, is dependent on the expected benefit to the public, the degree to which individual rights are restricted in order to achieve that benefit and that balance between the risks and harms to participants (Coughlin, 2006). However, the responsibility for change should perhaps not always lie with the general public. Findings could also suggest a need for the government to take constructive and voluntary measures to facilitate lifestyle and other changes which would be protective or promote the better health of the population (e.g. incentives to promote a healthy diet, increase exercise or promote social inclusion).
Non-research public health activities
Non-research public health activities occur when governments take action in the context of emergency situations in which an imminent health threat to the population has been detected (e.g. during the SARS epidemic). Sometimes, such action might seem to closely resemble research. According to Coughlin (2006), the difference lies in the purpose of the study. Non-research public health activities are generally aimed at rapidly determining the nature and magnitude of a problem, whether sufficient data is available to take action and whether causative factors can be detected so as to enable governments to rapidly implement appropriate measures. Another type of non-research public health activity is the regular, on-going surveillance of data pertaining to the frequency and distribution of diseases and health conditions in the population (Coughlin, 2006).
Activities may also be a combination of research and surveillance. In their 2007/2008 scientific report, the National Creutzfeldt-Jakob Disease and Surveillance Unit (NCJDSU) described their activities as follows:
“Surveillance and scientific research are both integral and interdependent components of the monitoring and investigation of Creutzfeldt Jakob Disease (CJD). Surveillance of variant and sporadic CJD by the National CJD Surveillance Unit (NCJDSU) provides data that are essential for informing a significant number of scientific research projects carried out in a wide range of professional fields at the NCJDSU, elsewhere in the UK, Europe and the world. While surveillance underpins this research, the findings of the research can also in themselves play an important role in surveillance, for example by providing sensitive and specific methods of diagnosis or by indicating specific risk factors to examine.” (NCJDSU, 2008, p.5)
The aim of such research is not to produce data which is generalizable to other populations, not to contribute to general knowledge about the condition and not to ask new questions or generate theory; the main aim is to deal with a current situation and the findings of such activities may well benefit those directly participating in the activities or the target population (Coughlin, 2006; Goodman and Buehler, 1996; Snider and Stroup, 1997). On the other hand, such activities may involve a research component even if this is not the main aim.
Similar methods may be used and the same rigorous approach to scientific research adopted. The question remains as to whether such activities are carried out ethically. In other words, as such activities are carried out by the state and in the light of an imminent danger or long-term threat, how are people’s rights and wellbeing protected? There may be some differences with regard to consent to participation (particularly voluntariness, being fully informed and coercive measures), privacy, confidentiality, dignity, stress and stigmatization).
There is also a power issue. The fact that such activities are organised by or through the state may have an impact on their perceived legitimacy and how the results are interpreted by the public (negatively or positively).
- Great care and sensitivity should be taken in the communication of the results of epidemiological research in order to reduce the likelihood of fear, stress and blame, and the stigmatization of those groups most affected by the findings.
- Efforts should be made to ensure the timely communication of findings to the widest possible audience.
- Efforts should be made to ensure the timely communication of findings to the group of people most likely to benefit from such knowledge in a way that is meaningful, credible and understandable to them.
- In the case of sub-groups of people with dementia, with whom it is difficult to communicate, assistance from representatives or facilitators should be sought.
- Ethical standards should be established for non-research public health activities involving the voluntary participation of the general public.
- Governments should be transparent about their role in research or non-research activities.
- Research protocols should address potential risks and possible solutions linked to the continuation of the study over a sufficiently lengthy period and to future challenges to the validity of the results of each study.
- Researchers involved in epidemiological studies should consider the possible future implications of their work on present and future populations.
Last Updated: Thursday 29 March 2012